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February 18, 2014
08:02 EDTEBIOEleven Biotherapeutics initiates Phase 3 clinical study with EBI-005
Eleven Biotherapeutics announced that patient randomization and dosing are underway in the company’s first pivotal Phase 3 clinical study of EBI-005 for the treatment of moderate to severe dry eye disease, the OASIS study. EBI-005, the Company’s most advanced product candidate generated using its AMP-Rx platform, is a novel, topically administered Interleukin-1 receptor blocker currently in development for the treatment of dry eye disease and allergic conjunctivitis. EBI-005 was designed to bind and block the IL-1 receptor to prevent transmission of biological signals responsible for many of the signs and symptoms of ocular surface diseases. This pivotal Phase 3 trial will include approximately 650 subjects in the U.S. Subjects will be randomized to receive EBI-005 or a vehicle-control. The co-primary endpoints of the study are change in corneal fluorescein staining score and improvement in pain and discomfort. The safety and tolerability of EBI-005 compared to vehicle-control will also be evaluated. This pivotal Phase 3 trial was designed based on the results observed in the company’s Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. Based on estimates of patient enrollment, the company expects that top line data from this pivotal Phase 3 study will be available in early 2015.
News For EBIO From The Last 14 Days
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May 19, 2015
08:12 EDTEBIOEleven Biotherapeutics price target lowered to $6 from $23 at Leerink
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May 18, 2015
16:21 EDTEBIOOn The Fly: Top stock stories for Monday
Stocks on Wall Street advanced in Monday trading, sending the Dow Jones Industrial Average and the S&P 500 to new all-time closing highs. The early part of the day saw the market move in a narrow range, but by early afternoon the market punched through its upper range and moved to session highs. The market drifted throughout the afternoon as the news flow was quiet and the trading volume remained light. ECONOMIC EVENTS: In the U.S., the National Association of Home Builders’ confidence index fell 2 points to a reading of 54 in May, missing expectations for a 1 point increase to a reading of 57. COMPANY NEWS: Shares of Apple (AAPL) advanced $1.47, or 1.14%, to $130.24 after noted investor Carl Icahn stated in an open letter to the company's CEO that he thinks other investors, analysts and the news media continue to misunderstand Apple and that its stock is "worth $240 today." Icahn urged Apple CEO Tim Cook to take advantage by launching a "much larger buyback" of the iPhone maker's shares. Separately, FBR Capital analysts Daniel Ives and James Moore wrote this morning in a note to investors that the Street is still underestimating Apple's growth outlook in China. The analysts believe that Apple's China revenue will exceed its revenue from the Americas in fiscal 2017... Endo International (ENDP) slid $4.53, or 5.31%, to $80.82 after the company agreed to pay $8B for privately held Par Pharmaceutical, which will roughly double Endo’s generics revenue and place its generics business among the top five as measured by U.S. sales. MAJOR MOVERS: Among the notable gainers was Ann Inc. (ANN), which surged $7.69, or 19.87%, to $46.40 after agreeing to be acquired by Ascena Retail Group (ASNA) for about $2.15B in cash and stock. Ascena, which agreed to pay $37.34 in cash and 0.68 of a share of its own common stock in exchange for each share of the parent of the Ann Taylor brand, slipped 14c, or 0.99%, to $14.07 after announcing the deal. Also higher was Achillion (ACHN), which rose $1.41, or 14.79%, to $10.98 after the company cancelled its presentation at the UBS Global Healthcare Conference. Conference cancellations often generate speculation as to whether a company is engaged in merger or acquisition talks. Among the noteworthy losers was Eleven Biotherapeutics (EBIO), which dropped $8.29, or 69.26%, to $3.68 after announcing the company’s Phase 3 study of its lead drug candidate, EBI-005, in moderate to severe dry eye disease did not meet either of its two co-primary endpoints. Also lower were shares of Weibo (WB), which fell 87c, or 5.24%, to $15.73 after the shares were downgraded to Hold from Buy at Summit Research. INDEXES: The Dow rose 26.32, or 0.14%, to 18,298.88, the Nasdaq gained 30.15, or 0.6%, to 5,078.44, and the S&P 500 added 6.47, or 0.3%, to 2,129.20.
09:25 EDTEBIOOn The Fly: Pre-market Movers
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07:33 EDTEBIOEleven Biotherapeutics resumes trading, shares down 70.8% in pre-market trading
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07:30 EDTEBIOEleven Biotherapeutics to host conference call
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07:15 EDTEBIOEleven Biotherapeutics to resume trading at 7:30 am ET
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07:03 EDTEBIOEleven Biotherapeutics will not initiate second Phase 2 study of EBI-005
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07:02 EDTEBIOEleven Biotherapeutics says Phase 3 EBI-005 study did not meet primary endpoints
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07:00 EDTEBIOEleven Biotherapeutics trading halted, news pending

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